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Everything you need to know about ISO 9001 Documentation Toolkit

 

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If you decide to go with self-implementation, you can find lots of resources and tools available to you, including free documents and downloads on the Internet. Our Virtual Consultant is here to offer independent advice you may not find anywhere else.

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More detail and advice in our ISO 9001 Blog

How to comply with ISO 13485:2016 requirements for handling complaints

Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and accuracy. Therefore, during the production, sales, and other customer-related processes, complaints are a vital and integral part of this industry. Complaint management is an important part of customer relationship management ...Read more

Specific use of ISO 9001 design and development in the machining process

With the updated Quality Management System (QMS) requirements in ISO 9001:2015, there have been some minor, yet important changes in the requirements for design and development activities within the Quality Management System. In the past, many companies have taken the opportunity to exclude the design and development activities required by ...Read more

Aligning quality objectives of the QMS with the strategic direction of the company

One of the new concepts that have been brought into the latest version of the ISO 9001:2015 standard is that the Quality Management System (QMS) of a company needs to include an understanding of, and alignment with, the strategic direction of the company. The strategic direction of the company comes ...Read more

How to deal with design and development changes in the technology sector using ISO 9001

The requirements of design and development are fairly prescriptive within the ISO 9001:2015 standard in terms of planning, inputs, outputs, controls, and changes to this process. For many organizations manufacturing standard products with little change, this is a vital and often straight-forward clause to follow, but when design and development ...Read more

How can ISO 9001:2015 help boost your sales activities?

While ISO 9001:2015 is strictly a quality management standard, it is considered a business tool by many people in today’s business environment. The benefits of implementing ISO 9001:2015 go far beyond the management of quality; it can also help your organization to improve performance, reduce supply chain costs, retain existing ...Read more

How to include statutory and regulatory requirements in your QMS

One of the requirements that are embedded within ISO 9001:2015 is the necessity to understand and include statutory and regulatory requirements within the Quality Management System (QMS); however, many people have difficulty with understanding how to do this. To help understand this process, there are three main questions to answer: ...Read more

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